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ISRCTN
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ISRCTN55110272
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of fissurectomy and botulinum toxin injection versus island flap in the management of chronic anal fissure
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0213168035
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Study hypothesis
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To determine whether fissurectomy and botox injection or island advancement flap is superior in the surgical management of chronic anal fissure.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Fissurectomy
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Participants - inclusion criteria
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1. Chronic anal fissure resistant to 6 weeks GTN therapy
2. Features of fissure chronicity (skin tag, induration)
3. Suitable for day case surgery
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Participants - exclusion criteria
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1. Concurrent peri-anal disease
2. Previous fissure surgery
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Anticipated start date
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01/08/2005
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Anticipated end date
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06/04/2007
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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35 patients in each arm.
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Interventions
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Anal fissure is a painful type of ulcer around the anal canal. It often does not respond to topical therapy and surgery has to be considered. Current treatment has a risk of incontinence after surgery. We wish to look at two different kinds of surgery which do not have any risk of disturbing continence, and decide which is superior in managing anal fissure. The first is surgical removal of the fissure together with an injection of botox. The second is surgical removal of the fissure with a flap of skin to cover the wound. Both techniques avoid cutting of the 'sphincter' and so do not disturb continence.
Added 28 August 2008: trial stopped due to poor recruitment.
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Primary outcome measure(s)
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Healing rates of anal fissure at 4, 12 and 24 weeks post surgery.
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Secondary outcome measure(s)
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1. Pain on defecation as assessed by Visual analogue score for 10 days post surgery
2. Patient's general health as assessed by SF-12 questionnaire at 24 weeks
3. Continence at 4, 12 and 24 weeks post surgery as assessed by the Cleveland incontinence score
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Sources of funding
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Royal West Sussex NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
NPJ
Cripps
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Address
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Royal West Sussex NHS Trust
St Richard's Hospital
Spitalfield Lane
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City/town
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Chichester
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Zip/Postcode
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PO19 6SE
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Country
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United Kingdom
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Tel
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+44 01243 831593
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Fax
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+44
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Email
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neil.cripps@rws-tr.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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06/10/2011
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Date ISRCTN assigned
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29/09/2006
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